NCT00212290

Brief Summary

The purpose of this study is to examine the effects of treating insulin resistance on memory and attention, brain glucose utilization, and proteins in spinal fluid.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2002

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2002

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

September 20, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

February 15, 2010

Status Verified

February 1, 2010

First QC Date

September 20, 2005

Last Update Submit

February 12, 2010

Conditions

Insulin ResistanceType 2 Diabetes Mellitus

Keywords

impaired glucose tolerance

Outcome Measures

Primary Outcomes (6)

  • Verbal memory (main study)

  • Selective attention (main study)

  • Plasma beta-amyloid levels (main study)

  • Cerebral glucose metabolism (sub-study)

  • Inflammatory markers in spinal fluid (sub-study)

  • Beta-amyloid in spinal fluid (sub-study)

Secondary Outcomes (3)

  • Psychomotor speed

  • Verbal fluency

  • Blood levels of insulin, insulin degrading enzyme, cortisol and inflammatory markers

Interventions

pioglitazoneDRUG
nateglinideDRUG
placeboDRUG

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Impaired glucose tolerance OR mild type 2 diabetes mellitus OR normal blood sugar regulation
  • Stable weight and activity level

You may not qualify if:

  • Medications for diabetes
  • Dementia
  • Medications with known effects on memory
  • Serious neurologic disease or head trauma
  • Serious systemic illness (e.g., renal failure or uncontrolled hypertension)
  • Serious psychiatric illness (e.g., schizophrenia or bipolar disorder)
  • Allergy to pioglitazone or nateglinide

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

VA Puget Sound Health Care System (Seattle Campus)

Seattle, Washington, 98108, United States

Location

VA Puget Sound Health Care System (American Lake Campus)

Tacoma, Washington, 98493, United States

Location

MeSH Terms

Conditions

Insulin ResistanceDiabetes Mellitus, Type 2Glucose Intolerance

Interventions

PioglitazoneNateglinide

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDiabetes MellitusEndocrine System DiseasesHyperglycemia

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Suzanne Craft, PhD

    VA Puget Sound Health Care System, University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

September 20, 2005

First Posted

September 21, 2005

Study Start

November 1, 2002

Study Completion

December 1, 2006

Last Updated

February 15, 2010

Record last verified: 2010-02

Locations

US(2)